A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects

NCT06159101 | Unknown Phase 1

• 1 other identifier: HLX13-001
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX13 with YERVOY® Injection in Healthy Chinese Male Subjects

Conditions

Healthy Male Volunteers

Keywords

CTLA-4

Outcome Measures

Primary Outcomes (2)

• Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf)

  Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  Up to Day 90

• Maximum (peak) serum drug concentration (Cmax)

  Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  Up to Day 90

Secondary Outcomes (7)

• Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)

  Up to Day 90

• Percentage of area under the serum concentration-time curve extrapolated to infinity (%AUCex)

  Up to Day 90

• Time to reach maximum (peak) serum drug concentration (Tmax)

  Up to Day 90

• Elimination half life (t1/2)

  Up to Day 90

• Total clearance (CL)

  Up to Day 90

Other Outcomes (3)

• Adverse events (AEs), serious adverse events (SAEs),

  Up to Day 90

• Incidence of anti-drug antibodies (ADAs)

  Up to Day 90

• Incidence of neutralizing antibodies (NAbs).

  Up to Day 90

Study Arms (4)

HLX13 group

EXPERIMENTAL

Recombinant anti-CTLA-4 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.

Drug: HLX13

CN-sourced ipilimumab group

ACTIVE COMPARATOR

CN-sourced ipilimumab

Drug: CN-sourced ipilimumab

EU-sourced ipilimumab group

ACTIVE COMPARATOR

EU-sourced ipilimumab

Drug: EU-sourced ipilimumab group

US-sourced ipilimumab group

ACTIVE COMPARATOR

US-sourced ipilimumab

Drug: US-sourced ipilimumab group

Interventions

HLX13 DRUG

A single dose (0.3 mg/kg) of HLX13 via intravenous infusion.

HLX13 group

CN-sourced ipilimumab DRUG

A single dose (0.3 mg/kg) of CN-sourced ipilimumab via intravenous infusion.

CN-sourced ipilimumab group

EU-sourced ipilimumab group DRUG

A single dose (0.3 mg/kg) of EU-sourced ipilimumab via intravenous infusion.

EU-sourced ipilimumab group

US-sourced ipilimumab group DRUG

A single dose (0.3 mg/kg) of US-sourced ipilimumab via intravenous infusion.

US-sourced ipilimumab group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to sign the informed consent form.
• Healthy Chinese males (no significant clinical abnormalities in medical history, physical examination, vital signs, chest X-ray, 12-lead ECG, and laboratory examinations).
• Age ≥ 18 and ≤ 60 years old.
• Body mass index (BMI) ≥ 18.5 and ≤ 28 kg/m2.
• Left ventricular ejection fraction (LVEF) \> 50%, as measured by echocardiography within 14 days before randomization.
• Subjects either agree that they and their spouse/partner will take reliable contraceptive measures within 3 months after the end of drug infusion or be infertile.

You may not qualify if:

• History of any severe hematological or renal, endocrinic, respiratory, gastrointestinal, cardiovascular, hepatic, neuropsychiatric, or neurological diseases or tumors.
• Use of a monoclonal antibody or any biological product within 6 months prior to the study treatment.
• History of allergy or anaphylaxis, including that due to any drug or drug excipients in clinical studies.
• Use of prescription/over-the-counter drugs or traditional Chinese medicines (except vitamins, mineral supplements, and health products) within 28 days prior to the study treatment.
• History of blood donation within 3 months prior to the study treatment.
• Participation in another clinical study and use of a clinical investigational drug or reference product within 3 months prior to the study treatment, or planning to participate in another drug clinical trial during the study period.
• Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
• History of drug abuse, or positive urine drug screen during the screening period.
• Have undergone surgery within 3 months before screening or plan to undergo surgery during the study period; have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion.
• Have been vaccinated within 28 days prior to screening or plan to be vaccinated during the study.
• Intolerant to venipuncture or with a history of needle or blood phobia.
• People on special diets who reject the arranged meals.
• Smoking more than 5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the study.
• An average daily alcohol intake of more than 15 g (equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol liquor) within 1 month prior to screening; or a positive blood alcohol test at screening; or unwilling or unable to abstain from alcohol during the study.
• Failure to comply with protocol requirements and instructions, protocol restrictions, etc., as judged by the investigator; uncooperative or unable to return to the study site for follow-up visits or complete the entire clinical study process, etc.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Anhui, Anhui, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Insulin-Dependent, 12

Study Officials

• Hu Wei

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hu Wei

CONTACT

+86-0551-65997165

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: November 28, 2023
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)